SarcopeniaNCT02533063
Semi-Recumbent Vibration Therapy in Older Adults
A study testing VibeTech One in people with Sarcopenia and Aging, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This proposed prospective study will evaluate whether a novel exercise approach, seated vibration therapy, can improve function in the target population of older adults. Therefore, the primary aim of this pilot is to examine the effect of vibration therapy on muscle function (balance, muscle power and strength) and… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Aging
- What is being tested?
- VibeTech One
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 15 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women age ≥ 70 years
- Able and willing to sign informed consent
- Able to stand without assistance
- Able and willing to train for 10 minutes, 3 times per week
- Total SPPB score of ≤ 9 or ≤ 2 in any of the three tests included in the SPPB
Who cannot join
- Cognitive impairment to the degree that it limits the ability of signing informed consent
- Unable to sit upright for 10 minutes
- History of injury or surgery within the prior six months which limits the ability to ambulate
- Major illness that might cause missed training sessions or visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jewish Home and Care Center
Milwaukee, Wisconsin, 53202
About this study
This proposed prospective study will evaluate whether a novel exercise approach, seated vibration therapy, can improve function in the target population of older adults. Therefore, the primary aim of this pilot is to examine the effect of vibration therapy on muscle function (balance, muscle power and strength) and muscle mass.
Read the detailed description
There are four study visits; screening/baseline followed by eight weeks of training three times a week, visit 1 at eight weeks followed by 4 weeks of washout, Visit 2 at 12 weeks followed by eight weeks of training three times a week, and a final Visit 3 at 20 weeks.
At the screening visit, volunteers will be asked to perform tests included in the short physical performance battery (SPPB) (gait speed, chair rise, balance). If the participants score is ≤ 9 or ≤ 2 in any of the three tests included in the SPPB they will be eligible for the intervention phase. At the baseline visit several questionnaires will be obtained and participants then will proceed with muscle function tests (SPPB, jumping mechanography, grip strength, timed-up-and-go test).
Participants will then be randomized into one of two groups. The first group will receive vibration + loading treatment for the first 8 weeks, the second group will receive sham treatment (loading only). After 8 weeks both groups will go through a 4 week wash-out period and then crossover will occur. The first group will now receive sham treatment (loading only) while the second group will receive vibration + loading treatment. The participants will train for 10 minutes, 3 times a week, during the active 16 total weeks.
- Conditions
- Sarcopenia, Aging
- Being tested
- VibeTech One
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibeTech OneDevice
Vibration Training The VibeTech One Rehab Chair allows vibration exercise while seated. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week. In the "loading + vibration group" (intervention group) vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max out at 1.0 g.
| Study group | Role | What they receive |
|---|---|---|
| Combination Treatment | Active comparator | In the "loading + vibration group" (intervention group), subjects will be seated in the VibeTech One system and vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max out at 1.0 g. Receives: Device: VibeTech One |
| Sham Treatment | Sham comparator | In the "loading only" group (control group) participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device. Receives: Device: VibeTech One |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate
The primary aim of this pilot is to examine the effect of vibration therapy on muscle function. Weight corrected jump power will be the main outcome variable. Countermovement jumps are performed on a Leonardo force plate (Novotec Medical, Pforzheim, Germany) following standard procedures. Jumping mechanography uses maximal countermovement jumps to quantitatively measure muscle strength in the legs. Participants will be asked to perform three countermovement jumps. Participants are asked to try to jump as high as possible using both legs. Three jumps are performed; the jump with the highest jump height is used for analysis.
Measured: This was collected 4 times: Baseline, after 8 week loading/loading+ vibration training, after 4 week washout, after 8 week crossover training.
Secondary outcomes (6)
Grip Strength
Grip Strengthwas acquired using a JAMAR hand dynamometer in the routine clinical manner. Measurements were recorded using participants' non-dominant hand and repeated 3 times to determine maximum grip strength.
Measured: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Gait Speed
Gait speed will be measured by instructing participants to walk four meters at their normal pace; they are timed with a stopwatch. This test will be repeated twice. The walk performed in the least time will be utilized for scoring purposes.
Measured: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Sway
Sway is assessed by having the participants stand with feet being placed side by side for ten seconds. Participants will be wearing MobilityLabTM (APDM, Portland, OR) sensors on their chest, lower back, wrists and feet during these tests to collect computerized sway data.
Measured: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Short Physical Performance Battery (SPPB)
The short physical performance battery (SPPB) consists of gait speed as determined by a four-meter walk, timed repeated chair rise and standing balance. Gait speed will be measured by instructing participants to walk four meters at their normal pace; timed with a stopwatch and is repeated twice. The walk performed in the least time will be utilized for SPPB scoring purposes. The timed repeated chair rise has participants stand up from a chair five times without the use of their arms, if possible. Time to complete five stands is measured. Standing balance is assessed by having the participants stand in three positions of increasing difficulty for 10 seconds each. Standardized instructions will be given to all participants and the test performed twice. The SPPB will be conducted and scored in standard manner, score 0-12, with lower scores indicating mobility limitations. Participants will be wearing MobilityLabTM sensors to collect computerized data for these tests.
Measured: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Timed-Up-and-Go (TUG)
The Timed-Up-and-Go (TUG) test will be performed twice; participants will be seated in an armless chair, upon instruction, they will be asked to stand, which starts the timing, they will walk 3 meters past a mark on the floor at their normal pace, turn around and return to a full seated position, at which time the test will end.
Measured: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Bioelectrical Impedance Spectroscopy (BIS)
An ImpediMed SFB7 device (Eight Mile Plains, Queensland, Australia) will be used to obtain these measurements. Participants will be positioned supine for a minimum of 10 minutes prior to acquisition; adequate separation of their legs will be obtained to allow for accurate BIS measurement. Measurements will be obtained by placing four EKG-like electrodes on the skin of the participant's hand, feet and knee. Wires will be attached from the BIS device to these skin electrodes. Painless electric waves will be sent through the tissues as noted above. Each measurement lasts only a few seconds. This method will generate measurements of lean mass.
Measured: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startNov 2015
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bjoern Buehring, M.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533063
- Sponsor's protocol ID
- 2015-0480
- Status last verified
- Mar 2019
- First submitted
- 19 Aug 2015
- Last updated
- 2 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Taani MH, Binkley N, Gangnon R, Krueger D, Buehring B. Effect of semi-recumbent vibration exercise on muscle outcomes in older adults: a pilot randomized controlled clinical trial. BMC Geriatr. 2022 Apr 18;22(1):335. doi: 10.1186/s12877-022-03052-0.
PubMed 35436920
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-Recumbent Vibration Therapy in Older Adults
- ClinicalTrials.gov ID
- NCT02533063
- Acronym / sponsor ID
- 2015-0480
- Conditions
- Sarcopenia, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Posted 2 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposed prospective study will evaluate whether a novel exercise approach, seated vibration therapy, can improve function in the target population of older adults. Therefore, the primary aim of this pilot is to examine the effect of vibration therapy on muscle function (balance, muscle power and strength) and muscle mass.
Detailed description
There are four study visits; screening/baseline followed by eight weeks of training three times a week, visit 1 at eight weeks followed by 4 weeks of washout, Visit 2 at 12 weeks followed by eight weeks of training three times a week, and a final Visit 3 at 20 weeks.
At the screening visit, volunteers will be asked to perform tests included in the short physical performance battery (SPPB) (gait speed, chair rise, balance). If the participants score is ≤ 9 or ≤ 2 in any of the three tests included in the SPPB they will be eligible for the intervention phase. At the baseline visit several questionnaires will be obtained and participants then will proceed with muscle function tests (SPPB, jumping mechanography, grip strength, timed-up-and-go test).
Participants will then be randomized into one of two groups. The first group will receive vibration + loading treatment for the first 8 weeks, the second group will receive sham treatment (loading only). After 8 weeks both groups will go through a 4 week wash-out period and then crossover will occur. The first group will now receive sham treatment (loading only) while the second group will receive vibration + loading treatment. The participants will train for 10 minutes, 3 times a week, during the active 16 total weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Treatment | Active comparator | Device: VibeTech OneIn the "loading + vibration group" (intervention group), subjects will be seated in the VibeTech One system and vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max out at 1.0 g. |
| Sham Treatment | Sham comparator | Device: VibeTech OneIn the "loading only" group (control group) participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Men and women age ≥ 70 years
- Able and willing to sign informed consent
- Able to stand without assistance
- Able and willing to train for 10 minutes, 3 times per week
- Total SPPB score of ≤ 9 or ≤ 2 in any of the three tests included in the SPPB
Key exclusion criteria (4 listed)
- Cognitive impairment to the degree that it limits the ability of signing informed consent
- Unable to sit upright for 10 minutes
- History of injury or surgery within the prior six months which limits the ability to ambulate
- Major illness that might cause missed training sessions or visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VibeTech OneVibration Training The VibeTech One Rehab Chair allows vibration exercise while seated. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week. In the "loading + vibration group" (intervention group) vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max out at 1.0 g. | Device | Combination Treatment, Sham Treatment |
Primary outcome
Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate
Time frame: This was collected 4 times: Baseline, after 8 week loading/loading+ vibration training, after 4 week washout, after 8 week crossover training.
The primary aim of this pilot is to examine the effect of vibration therapy on muscle function. Weight corrected jump power will be the main outcome variable. Countermovement jumps are performed on a Leonardo force plate (Novotec Medical, Pforzheim, Germany) following standard procedures. Jumping mechanography uses maximal countermovement jumps to quantitatively measure muscle strength in the legs. Participants will be asked to perform three countermovement jumps. Participants are asked to try to jump as high as possible using both legs. Three jumps are performed; the jump with the highest jump height is used for analysis.
6 secondary outcomes
Grip Strength
Time frame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Gait Speed
Time frame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Sway
Time frame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Short Physical Performance Battery (SPPB)
Time frame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Timed-Up-and-Go (TUG)
Time frame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Bioelectrical Impedance Spectroscopy (BIS)
Time frame: Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35436920Taani MH, Binkley N, Gangnon R, Krueger D, Buehring B. Effect of semi-recumbent vibration exercise on muscle outcomes in older adults: a pilot randomized controlled clinical trial. BMC Geriatr. 2022 Apr 18;22(1):335. doi: 10.1186/s12877-022-03052-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjoern Buehring, M.D. principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VibeTech One in people with Sarcopenia and Aging, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate (time frame: This was collected 4 times: Baseline, after 8 week loading/loading+ vibration training, after 4 week washout, after 8 week crossover training.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02533063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.